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Open Access Highly Accessed Study protocol

Smoking Cessation and Reduction in Schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial

Pasquale Caponnetto123*, Riccardo Polosa12, Roberta Auditore3, Giuseppe Minutolo34, Maria Signorelli4, Marilena Maglia123, Angela Alamo12, Filippo Palermo5 and Eugenio Aguglia4

Author Affiliations

1 Smoking Prevention/Cessation Centre, A.O.U, Policlinico-V.Emanuele, Department of Clinical and Molecular Biomedicine, University of Catania, Catania, Italy

2 Institute of Internal Medicine, AziendaOspedaliero-Universitaria “Policlinico-V.Emanuele”, Department of Clinical and Molecular Biomedicine, Università di Catania, Catania, Italy

3 CTA-Villa Chiara Psychiatric Rehabilitation Clinic and Research, Mascalucia, Catania 95030, Italy

4 U.O.P.I. of Psychiatry, Department of Clinical and Molecular Biomedicine, Policlinico-Vittorio Emanuele Hospital, University of Catania, Via Santa Sofia 78, Catania 95100, Italy

5 Department of Clinical and Molecular Biomedicine, A. O. “Garibaldi-Nesima”, University of Catania, Catania, Italy

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Trials 2014, 15:88  doi:10.1186/1745-6215-15-88

Published: 22 March 2014

Abstract

Background

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.

Methods/Design

Intervention: We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants’ perception and satisfaction of the product.

Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit (“reducers”). Abstinence from smoking will be calculated at each study visit (“quitters”). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of “reducers” and “quitters” will be defined “non responders”.

Statistical analysis: The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test.

Discussion

The main strengths of the SCARIS study are the following: it’s the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).

The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia.

Trial registration

ClinicalTrials.gov, NCT01979796.

Keywords:
Smoking cessation; Smoking reduction; Electronic cigarette; Schizophrenia clinical trial; Cognitive; Addiction; Quality of life